Perhaps one of the reasons that many of us are still divided on the concept of a small quality manual is that we have not truly considered and understood the actual requirements.  ISO 9001 requirements for a quality manual are: 

1. It must describe/define the scope of the quality management system,
2. It must explain any excluded elements/clauses,
3. It must define or reference the “documented procedures” that make up your quality management system, and
4. It must describe/show the interaction of the quality management system processes

At no point does ISO 9001 stipulate how long the quality manual should be.  It does not even say that it should be a singe document.  Nor does it suggest that it should even be in text format.

Another possible source of confusion and diverging opinions is the use of the terms “procedure” and “processes”.  We can all agree that the intent of ISO 9001 is to serve as a process management platform.  However, it only applies the word “documented” to procedures.  This begs the question: should we not document our processes?  For those of us that practice more that just ISO compliance, the answer is: of course we should.  If you agree, then replace the word “procedure” with “process” and think about the requirements again.  Now the QMS must:

1. Define or reference the “documented processes” that make up your quality management system, and
2. Describe/show the interaction of quality management system processes.

Why not draw a picture of this on one or two pieces of paper?  Why use paper? In my practice I do this all the time.  Hundreds of clients have embraced this approach and never has this been an issue with any registrar.  Granted, customers may want to see the details of the actual “documented process,” which is fine.  Show them the process(es) and show them how that process fits into the overall process based quality management system with your new short quality manual or Lean QMS^® Map.

Kirill Liberman, President

ISO 9001 certification has become almost synonymous with a bureaucratic documentation glut.  Most companies seeking ISO 9001 certification view it as a necessary evil for gaining access to key customers or markets.  The resulting quality management system (QMS) is viewed and functions as overhead.  Most companies never realize any actual intended benefit beyond a pretty certificate on a wall and access to a new customer or market.  Why is this so?  One reason is the all too common misconception of ISO 9001 as a set of documentation requirements.  While it is true that ISO 9001 stipulates certain documents and records, the intent and focus of the standard is not documentation.  In fact, very few documents are specifically required by ISO 9001.  Following is a list of all ISO 9001 required documents and records:

If you consider the required documented procedures carefully, you will agree that requiring six documents does not seem particularly bureaucratic.  Furthermore, it is certainly reasonable for any company to have a defined and consistent method for controlling its key documents and records.  Surely conducting self assessments (internal audits) to gauge how consistent, efficient, and effective an organization is at following its own business practices seems like common sense and good business practice.  And having a consistent process for dealing with nonconforming products or services should already be part of any business.  Finally, systematically taking action to correct or prevent problems hardly seems impractical and is not new to anyone.  It would appear that you should be doing these things already.  In fact, you probably are.  Furthermore, you are probably doing all of the things that ISO 9001 describes.  So, why is the intent of ISO 9001 so misunderstood and misapplied?

A major reason is that early interpreters and adopters of ISO 9001 were military and defense contractor quality folks.  They used the early 1950’s military approach to quality standards because they recognized some vestiges of MIL-Q-9858, which is an early ancestor of ISO 9001.  Bureaucracy and a documentation glut is what they knew.  The result was that the intent and requirements of ISO 9001 were interpreted through the lens of military and defense contractors.  This resulted in the following documentation-centric paradigm that still persists today:

While this paradigm may be appropriate for describing a documentation structure for a government or military agency, commercial enterprises rarely operate in this way.  In fact, this paradigm is typically the cause of over documentation.  The resulting paperwork glut quickly becomes “shelf-ware” and a burden to a business.

The fact is that ISO 9001 does not stipulate this pyramid of documentation.  Nor does it make any suggestion regarding the form and structure of QMS documentation.  ISO 9001 simply describes the minimal elements or components that a basic quality management system should have.  It is simply a platform and structural framework for a quality management system, not a set of documentation requirements.  As I mentioned above, you are probably doing these things already.  If so, your ISO 9001 quality management system documentation should support your current business practices.  ISO 9001 gives you the freedom to structure your documentation to suit your particular organizational needs.

As an antidote to the pyramid paradigm above, I utilize the following documentation hierarchy:

This structure gives a business the flexibility to structure its documentation in any way that makes sense for the company.  For example, when a well designed form provides all of the instructions and work flow necessary to complete a particular function, as well as collect any required information, then there may be no need for a procedure and/or a work instruction.  Nothing in ISO 9001 prevents you from doing this.  On the other hand, if you determine that you need to have multiple layers of documentation, you have the freedom to do so too.  In fact, both scenarios can exist in the same ISO 9001 compliant quality management system.  This documentation hierarchy does not force you to create non-value-added documents when and where they are not needed.

There are many methods for eliminating the “documentation glut” and improving the value of the ISO 9001 quality management system documentation.   One example is the replacement of the traditional 50-100 page Quality Manual with a more modern 1-3 page version, like the Lean QMS^® Map that I utilize.  I wrote about this approach in “The Modern Quality Manual.”  The result can be an up to 80% reduction in the volume of ISO 9001 documentation.  More importantly, however, the remaining 20% will have at least 80% more value to your business.  Look for the next installment in this ISO 9001 Myth series:  “ISO 9001 Myth #2 – “Say What You Do & Do What You Say.”

Kirill Liberman, President

Believing they must write down everything they do, many companies engage in a massive documentation exercise.  “Say what you do and do what you say” has led companies to the misconception that their mission in implementing ISO 9001 is to document everything that everyone does; and that the resulting documentation will adequately and even impressively represent how the business operates.  While implementing ISO 9001 is a time to document how you do business, it’s not a time to illustrate every possible detail of the company’s daily activities.

The fact is, having every activity in the company documented (e.g. detailed work instructions) doesn’t ensure these activities are actually performed effectively, efficiently or even consistently.  Paper is not a replacement for motivated, competent, and capable employees who work within a well-designed process.

Furthermore, by assuming “say what you do and do what you say” implies that more documentation is better; companies often paint themselves in a corner.  Frequently they develop sets of procedures that actually stifle the creativity and flexibility of a talented workforce.  In our ISO 9001 consulting practice, we typically see this scenario at clients that have an ineffective human resource development process (e.g. training, competency development, etc.) and have tried to compensate by developing detailed work instruction and other documents for every activity.

A successful ISO 9001 implementation should begin with the identification and rationalization of KEY business processes (not procedures).  Developing an ISO 9001 quality management system presents a company with the occasion to bring key business processes to light and represent them in a way that is understood clearly by everyone in the company.  To put it simply, you need to be focused on value-added content when creating your ISO 9001 documentation, not just large amounts of content.

To begin with, the minimum requirement for ISO 9001:2008 is a quality manual, six documented procedures (I call these support processes), and 21 records.  This requirement does not assume any particular organizational size or complexity, so it stands to reason that even large organizations could potentially develop a fairly lean set of documents.  It’s also possible for a smaller organization to have fairly complex operations, resulting in more documentation.  In my experience, every company will exceed the minimum ISO 9001 documentation requirement.

Keep in mind that many processes and systems in your business are not unique.  How you manage them and their interaction with unique processes defines your business operating system.  The ISO 9001 quality management system simply provides the foundation and structural framework on which to build your business operating system.

ISO 9001 doesn’t require a high level of detailed documentation.  Instead, the intent of ISO 9001 is to first accurately describe the processes which make up your business operating system and demonstrate their relationship to and interaction with one another.  The second intent is to demonstrate that your business operating system is effective at exceeding customer expectations and meeting internal business objectives.  If you cannot clearly and positively demonstrate that you have fulfilled these two intents, then saying what you do and doing what you say does not matter.

Please stay tuned for my next installment in this ISO 9001 Myth series:  “ISO 9001 Myth #3 – Failing ISO 9001 Certification.”

Kirill Liberman, President

First, it’s important to realize that registrars are not in the business of failing their customers and auditors are not looking for reasons to fail you.  Auditors are looking for reasons to pass you.  In fact, they want you to pass.  The objective of a good auditor is to understand your quality management system and communicate with you to justify that your processes are effective and compliant with ISO 9001 requirements.  Although many of my ISO 9001 consulting and training clients imagine auditors as people who are difficult to work with; typically auditors are not trying to play “gotcha.”  In reality, you have to try hard to screw up an ISO 9001 certification audit that is properly prepared for.

Second, the auditor is measuring you against a basic set of requirements.  As I have discussed in previous articles, ISO 9001 is a minimal set of generic requirements.  Consequently, the auditor’s charter is to assess whether your company meets these minimal levels.  Since ISO 9001 is a quality management system framework and a platform for continual improvement, the auditor is not so interested in whether your company has realized every value-added potential for the business.  Sure he or she may note opportunities for improvement, bring some things to light, and even make some recommendations “off the record.”  But if you’re meeting the stated ISO 9001 criteria for a quality management system, then your auditor is typically anxious to report that your ISO 9001 implementation is successful.

Finally, if your company really is too screwed up to pass, this should be caught long before your certification audit.  The first line of defense should be your ISO 9001 consultant.  He or she should suggest that you postpone the certification until you are truly ready.  If the ISO 9001 implementation was done internally without the aid of a competent consultant and your company has begun the certification process only to find that failure seems possible or imminent, then your registrar may be more to blame than your quality manager or implementation team.

One of the first steps of the ISO 9001 certification process is the “stage one readiness assessment.”  Your auditor should note any red flags or significant concern as you cross the stage one toll gate.  By the time the stage two certification audit takes place, the path to successful compliance should be readily apparent and there should be no major nonconformances.

The truth is an auditor who issues failures with any regularity is an issue in itself.  The ISO 9001 auditor is a key component in the ISO 9001 certification process and should be communicating whether the organization is ready to proceed.  Your auditor should be looking to work with you to stand up a lean, value-added business operational system that meets minimum requirements and positions the company for continual improvement.

So that begs the question – “Does failing happen?”

Unfortunately there is the occasional situation where the auditor does not recommend the company for ISO 9001 certification.  This is usually due to extraordinary circumstances.  Sometimes a company going through a merger, opening new facilities, changing facilities, or changing leadership may make assumptions about the business operations based on the current state which simply cannot be carried forward.  Even if the existing systems have worked well in the past, if it can’t bear the organizational and operational changes, this may provide grounds for an unsuccessful ISO 9001 audit.  These situations aren’t typical but they do happen.

Many audits will end with the report of some minor nonconformities (the national average is 4-6; Pinnacle’s average is less than 1).  Does this mean failure is on the horizon?

Most of the time when minor nonconformities are reported there is ample time to correct them; sometimes prior to the auditor even leaving the facility or in a few days or weeks after the auditor makes his recommendation but before certificates are issued by the registrar.  The auditor may offer to recommend your company pending receipt of corrected minor nonconformities, so you still don’t fail; you just have some additional work to do prior to the auditor’s recommendation.

The bottom line is that no company should worry about passing or failing your audit.  ISO 9001 implementation and certification are not about collecting another plaque for the lobby.  The process is about developing, maintaining, and evaluating a business operating system that works well and positions your business for success.  Align your business processes with best practices, create lean value-added documents, be able to demonstrate that your quality management system is effective and your ISO 9001 certification will be a byproduct and a positive force to move your company to continual improvement.

Maintaining ISO 9001 certification (or ISO 14001 and OHSAS 18001 certification, for that matter) requires thorough, regular internal audits.  Clause 8.2.2 of ISO 9001 and clause 4.5.5 of ISO 14001 and OHSAS 18001 stipulate this.  Furthermore, clause 6.2 Human resources of ISO 9001 and its ISO 14001 and OHSAS 18001 counterpart, clause 4.4.2 Competence, training and awareness, require that your staff be appropriately qualified, trained, and competent.  Unfortunately, many extrapolate and exploit these requirements to mean that formal Lead Auditor Training is required to implement and maintain a formal internal auditing program.  They then rush out and pay $1300 to $1800 per person for this training, which also takes them out of their jobs for a week, in the hope of honing their internal auditing expertise.  A careful reading of these clauses however, reveals that at no point do they state or even imply this requirement.

This myth lies somewhere between a problem with semantics and well-intentioned management teams trying to do the right thing for their companies.  Plenty of encouragement to move in the direction of ISO 9001 and ISO 14001 Lead Auditor Training can be found online and in print.  The problem:  all of the propaganda telling you that your people need these training courses is created by those who profit from selling you the training.  So well-meaning organizations send off their finest to prepare to lead and conduct internal audits.

Still not convinced that your people and your company do not need Lead Auditor Training?  Consider the following facts:

1. Lead Auditor Training was developed for and is only required of those individuals who intend to pursue a career as a third party auditor working for a registrar.  In other words, if your company is not a registrar, then you would be paying to train your people for a new career with another company.
2. Completing a Lead Auditor Training course does NOT provide a Lead Auditor credential.  Yes, you read this correctly.  A Lead Auditor Training certificate is just a prerequisite for applying to RABQSA for evaluation.  Before becoming a Lead Auditor, there are still professional requirements that must be met, including conducting a number of “verifiable audits,” educational requirements, work experience, and sponsorship by an actual accredited registrar.

I’ll put it another way:  if registrars and accreditation agencies know that ISO 9001 and ISO 14001 Lead Auditor Training courses do not provide an individual with tactical or tangible external auditing skills, why should your company invest in them for internal auditing?

Still not convinced?  Then consider that ISO 9001 and ISO 14001 Lead Auditor Training are generic.  Because of RABQSA course accreditation guidelines one course provider cannot waiver much from another.  In all cases the courses are designed to fit any participant, regardless of his or her industry and experience.  Consequently, when members of a metal fabrication company, for example, attend a week-long course they may find themselves in a class with representatives from a chemical R&D company, a distributor, an IT services company, and a hospital.  All of the course material, examples, and exercises are therefore generic.  Then it’s up to your people to translate the “ISO knowledge” to your industry, your specific company, and your specific business system.

What your company and your people really need is internal auditor training designed to teach them how to audit your specific company and its quality or environmental management system.  Here again there is a plethora of providers eager to relieve you of your training budget.  But you should be wary of public, generic courses for the reasons I described above.  Canned internal auditor training simply is not very effective.  A truly custom designed ISO 9001 internal auditor training and ISO 14001 internal auditor training programs works best, but they are fewer and harder to find.

A true custom-tailored ISO 9001 internal auditor training provider will first need to learn about your company and your quality management system (QMS).  The course material, examples, and exercises would then be developed from your actual QMS.  Custom designed internal auditor training programs are typically 2-3 days long.  A good ISO 9001 internal auditor training program will have a workshop format that devotes at least half of its time to practicing actual internal auditing within your facilities.  This approach affords your people a learning environment that matches their daily work environment.  The transfer of knowledge and skills is simply more direct, resulting in greater retention and practical skills development.

Pinnacle no longer provides ISO 9001 Lead Auditor Training.  For the reasons I described above, we simply see no value in it for our clients.  Instead, we focus on providing high-value internal auditor training workshops that are always tailored to individual customers.  In fact, we even offer an internal auditor mentoring program that develops internal auditors over the course a several actual internal audits.  The results are even more effective.  My point is that you should question the common auditor training assumption and ignore the hype.  Carefully consider what you really want from your internal auditors.  Do you just want them to help you keep a pretty certificate on the wall or do you want them to help drive business improvement?  Sure, there is a bit of self-promotion here, but my reasons are good and my intentions are pure.

Kirill Liberman, President

In short, this debate is about semantics.  I happen to prefer “process” over “procedure” because, for most people, the term “procedure” carries the connotation of a document, as it does in ISO 9001 and all other ISO standards.  But in Pinnacle’s ISO 9001 consulting practice I guide clients away from thinking about documents first.  The goal is NOT to create documents.  The goal is to identify, define, control, and improve the activities and functions (whatever you call them) that make an organization?

Some critics and ISO 9001 traditionalists argue that these two terms are entirely “different animals.”  Let’s examine this.  Webster’s defines the word procedure as “the act or manner of proceeding in any action or process” and “a particular course or mode of action.”  The word process is defined as “a systematic series of actions directed to some end” and “a continuous action, operation, or series of changes taking place in a definite manner.”  We can all agree that these are at least members of the same species.  A simpler way to paraphrase these definitions is to say that a process is “what we do” and a procedure is the “how we do it.”  In reality, management teams must understand and manage both simultaneously.  Consequently, an ISO 9001 QMS must effectively and efficiently address both simultaneously, if it is to be of any value.  It is advantageous if this could be done with as few layers and number of documents as possible.  In the day-to-day operational reality of any organization a process and procedure are more than just members of the same species.  They are parts of the same “animal” called the business operating system.  So why get hung up on how we clearly separate them?

One recent critic, who is an ISO 9001 consultant and claims to be a volunteer member of the US TAG, made the astounding claim that a process is “invisible” and “conceptual.”  He used “Production” as an example of a conceptual and invisible process.  His argument is that “Production” is invisible and conceptual because it existed before any documents were written.  This kind of logic would be comical, if it did not come from an actual ISO 9001 consultant and if it was not shared by others who claim to be ISO 9001 professionals.  This just reinforces the old adage of “buyers beware.”

I find this kind of “religiousizng” of basic ISO 9001 concepts disturbing.  It is this kind of ISO 9001 dogma, veiled in the debate about semantics, which has plagued our industry and has diminished the value of ISO 9001 certification.  Business processes, like “Production,” do not come into existence by some mystical force.  They are engineered by people.  The fact that a process may have been designed poorly or was not documented does not make it any less real or tangible.  Furthermore, calling “Production” a single process is shortsighted.  In most cases, “Production” actually consists of several processes (not procedures).  For example, in a typical manufacturing company what this critic’s camp would call “Production” is more likely a sequence of processes like this:

What would the old guard call these?  Sub-processes perhaps?  Will we need yet another document layer?  Some of these processes (as I would call them) may require supporting procedures such as, Material Staging, Machine Set-up, First Piece Inspection, etc.  Where do we draw the line between the process and procedure?  Furthermore, these processes are typically supported by other processes like Training, Document Control, Preventive Maintenance, Corrective Action, etc.  Critics and ISO 9001 dogmatists would probably have us call these support processes something like “Administration.”  From their perspective every company would have essentially the same set of processes:

1. Customer Acquisition & Onboarding
2. Design/Engineering (if this is applicable)
3. Production
4. Support Activities & Administration

What value would this provide to the management and employees of an organization?  Furthermore, why should we even concern ourselves with which term we use and when we it? These four so called processes seem more like departments. Some fail to realize that processes are not departments. Processes cross departmental boundaries: Onboarding a customer requires Sales to collaborate with Engineering and Production, designing a product requires Engineering to collaborate with Sales and Production, and so on. It is this collaboration and interaction at the process level that management teams and employees must understand, define, control, and improve.

We must remind ourselves that ISO 9001 is nothing more than a guide to the minimal elements that a quality management system should include.  It is not an advanced document nor is it a perfect guide.  It is, however, made less valuable by interpretations that treat it like a business gospel and construct non-value-added dogma.

Finally, we must deal with the concept of the Work Instruction.  In Pinnacle’s Lean QMS^® methodology, Work Instructions are the equivalent of what ISO 9001 traditionalist call procedures.  The interesting thing is that most traditionalists also employ Work Instructions.  No one will deny that Work Instructions are a reality in most organizations, but I find that these are usually better classified as training or reference documents.  Nevertheless, there is no denying that Work Instructions describe “the act or manner of proceeding in any action or process” and “a particular course or mode of action.”  While ISO 9001 does not stipulate the creation of Work Instruction, standards like ISO/TS 16949 do.  Does this mean that we must now debate the semantics of a Procedure versus a Work Instruction?  Who cares?  The bottom line is that an organization should define and document its management system in a way that is effective and efficient for the organization.  The byproduct will be ISO 9001 certification, regardless of what we call the documents.

Greg Stanton, Laboratory Manager

Outcome:
Scripps Laboratories uses Pinnacle’s Lean QMS® methodology to achieve ISO 9001 certification, simplify processes, reduce documentation, and increase collaboration.

Industry:
Biomedical, Biochemical Manufac

Objective:

• Develop modern and practical quality management systems.
• Create sustainable platform for continuous improvement.
• Improve staff involvement and cooperation.
• Replace bloated library of text documentation and eliminate resistance to ISO 9001 documentation.
• Regain control of the ISO 9001 implementation process.

Approach:

• Use Pinnacle Enterprise Group’s Lean QMS® approach to:
  1. Identify and focus on key business processes,
  2. Efficiently manage the ISO 9001 implementation, and
  3. Achieve ISO 9001 certification.

Benefits:

• Everyone understands key business processes, their contribution to the processes, and process interactions.
• Everyone actively participates in the management system.
• Increased productivity from improved collaboration.

ISO 9001 Certification and Lean QMS® Facilitates Collaboration

Scripps Laboratories is a San Diego based manufacturer of proteins and immunoreagents. The company specializes in the sale of bulk quantities to the diagnostic industry and research facilities. For Scripps, the benefit of ISO 9001 certification was not a consideration. It was viewed as a necessary step to benefit business operations.

The company had previously implemented FDA 21 CFR 820 (QSR), a government requirement for an invitro diagnostic product which they no longer manufacture. So when competition and customer requirements directed them toward ISO 9001 certification, they began to work internally to implement the requirements, patterning the implementation after the FDA QSR program. In the case of Scripps Laboratories, the real business improvements are observed when comparing the company’s preconceptions and initial experiences in implementing ISO 9001 requirements (text based FDA QSR mode) to the quality system now used in daily operations.

Process and Documentation Misconceptions

Because of early misconceptions of “processes” vs. “tasks” within a process, Scripps tended to create excessive documentation. For their 400+ products they identified 60-70 unique processes. As a small operation with a lean workforce the effort required to document and maintain these processes was such an intrusion to the business that they elected to hire a full-time employee just to create the manuals and focus on the ISO certification project.

Even with this addition to the team, the ISO 9001 certification project and the materials created remained disconnected from the business. “We kept hitting roadblocks,” states Gabriele Noll, a senior team member who is responsible for purchasing. “Our purchasing process was an aggregate of 10-12 pages long. The process and related forms were far too cumbersome to be used effectively,” adds Noll.

It was Scripps’ auditor that first referred the company to Pinnacle Enterprise Group for guidance in their implementation. Scripps’ preconceptions dictated their initial response when Pinnacle President Kirill Liberman introduced his Lean QMS® to the company. “That would never work here – it’s not complicated enough,” were the kind of comments received from the Scripps team. It took several weeks of consideration while continuing to create volumes of documentation for “this might work” to become an internal directive to utilize Pinnacle’s visual-based Lean QMS® methodology.

Fewer Processes, More Collaboration

The first thing Pinnacle’s Lean QMS® allowed Scripps to do was to discover and understand what the company’s key processes really are. The result allowed Scripps to pare down their processes significantly. They went from 60-70 manufacturing processes to fewer than 10; each with 4-5 discreet functional steps.

Second, the Lean QMS® visual documentation actually gave everyone a real understanding and visibility of the business. By using the Lean QMS® documentation, anyone on the Scripps team could see any process and understand how it relates to the entire business. “The visuals allow you to grasp how the processes interrelate to each other – hard to see in the text version,” comments lab manager Greg Stanton who also serves as the ISO 9001 management representative.

The most important value for Scripps in using the Lean QMS® is found in their improved collaboration. The Lean QMS® gives visibility to process steps that were previously available only to certain individuals.

Many of the Scripps protein purification processes contain manufacturing steps which need to be followed in specific sequences over 3-6 months or longer. Prior to the Lean QMS®, only the person involved or a person with a particular specialty or authorization knew where the products were in the process. This required them to be involved in each step. By using the operational systems developed with the Lean QMS®, including a newly created “smart” numbering system, qualified team members can step in any time to advance the products through the process.

This level of collaboration helps utilize everyone in their most productive capacity. “Everyone in the lab has now become participants rather than observers,” states Lab Manager Stanton.

Now Scripps improvements are not only recorded in the ISO 9001 quality management system documentation, but are actually facilitated by the documentation. The company’s continual improvements grow out of their ability to visualize the business and act efficiently using the information provided through the Lean QMS®. Maintaining ISO 9001 certification is no longer an effort or an objective; it is a byproduct of routine operations.

Corbin Kearns, Plant Manager

Outcome:
Johnson Matthey, Smithfield, PA uses Pinnacle’s Lean EMS® methodology as a framework to achieve ISO 14001 certification and lay a foundation for achieving global environmental sustainability objectives.

Industry:
Automotive OEM Manufacturing, Chemical

Objective:

• To develop a robust EMS that can evolve as production grows, consistent with Johnson Matthey’s global environmental sustainability values.
• Achieve ISO 14001 certification.
• Minimize bureaucracy and EMS management overhead.

Approach:

• Use Pinnacle Enterprise Group’s Lean EMS® to guide us through the process efficiently.

Benefits:

• Rapid implementation and certification.
• A robust EMS ready for immediate use and easy to manage.
• User-friendly documentation improved training effectiveness and ownership.

Lean EMS® Supports Commitment to Sustainability

One of Johnson Matthey’s newest plants is located in Smithfield, PA. The new facility is part of the Environmental Technologies Division within Johnson Matthey’s worldwide manufacturing operations. Johnson Matthey Smithfield manufactures catalysts for the automotive and diesel truck markets, so they are very much interested in pro-active environmental leadership both internally and toward their customers.

One of the first items of business when the plant opened in August 2009 was to put a stand alone Environmental Management System in place that would reflect Johnson Matthey’s global sustainability priorities as a company, serve as a foundation for operating the business and become a scalable tool as the facility evolved. A rapid implementation was not the first priority, but the company wanted to have the system in place early in the life of the facility.

Plant manager Corbin Kearns and Health and Safety Engineer Mary Lynn Seremet both had previous experience with environmental management systems, so when they evaluated a partner for guidance in the implementation, Pinnacle Enterprise Group’s Lean EMS® was especially interesting to them.

“The approach was attractive because it seemed very straightforward,” stated Kearns. “It’s intuitive and because it’s visual-based it seemed easier to follow than traditional text-based systems.”

Johnson Matthey Smithfield had already decided that settling for an ISO 14001 certification alone would have little benefit to them. They were interested in using the opportunity of their ISO 14001 EMS implementation to create a useful system, a foundation which could be built upon for continual improvement. According to Corbin and Mary Lynn, that is exactly what they have achieved.

Pinnacle’s Lean EMS® helped the company to create a basic set of processes and documents which left a solid framework specific to Johnson Matthey Smithfield’s requirements. According to the leadership, it gave them a starting point which was already robust, so it could be easily added to and improved upon, but it was also immediately useful in the day to day operations.

The characteristic of the project that pleased the company most was that they actually were not surprised by anything. The ease of implementation in working with Pinnacle performed to expectation in every way.

Pinnacle took them step by step through development of the lean visual system. The company completed the process in less than 5 months and passed the ISO 14001 certification audit with 0 nonconformances. When the certification was complete, Johnson Matthey Smithfield possessed an intuitive system that was simple for everyone to use and added value to the business.

Jeffrey Joaquim Senior Manager, Corporate EHS

“Although it appeared that ISO 14001 and OHSAS 18001 were going to burden the factory with some unnecessary tasks; during the training and after the certification we realized added value and cost savings.”

Greg Safarik, Vice President, Breast Health Manufacturing Operations

Outcome:
Using Pinnacle Enterprise Group’s Lean EHS®, Hologic achieves a combined ISO 14001 and OHSAS 18001 certification in 7 months.

Industry:
Medical Device Manufacturing, Diagnostics

Objective:

• Develop an integrated and sustainable Environmental, Health, & Safety Management System (EHS).
• Seamlessly integrate and streamline the ISO 14001 and OHSAS 18001 certification process.
• Achieve ISO 14001 and OHSAS 18001 certification simultaneously.
• Improve access to broader global markets by meeting international environmental, health and safety requirements.

Approach:

• Use Pinnacle Enterprise Group’s Lean EHS® to:
  1. Build unity and ownership of the EHS.
  2. Take advantage of the synergies of ISO 14001 and OHSAS 18001.
  3. Efficiently manage the integration and implementation of ISO 14001 and OHSAS 18001.

Benefits:

• Reduced product standard cost & operational overhead.
• Reduced Accident Incident Rate.
• Energy conservation in the areas of power, air, and waste.
• Total company awareness and involvement in environmental, health and safety.
• Reduction of the company’s overall environmental footprint.
• Reduction of the overall environmental footprint of suppliers.
• ISO 14001 and OHSAS 18001 certification with zero non-conformances in less than 7 months.

The Industry Leader

Hologic is a manufacturer and supplier of diagnostic medical imaging systems and surgical products focused on women’s health. The company is the leader in mammography, breast biopsy, and other technologies related to detection and treatment of cancer and other women’s disease.

Hologic’s Breast Imaging Solutions manufacturing site in Danbury, CT is not a stranger to management systems. In the medical device industry, quality and advanced management methods are a must to ensure operational excellence on a highly competitive landscape. The company enjoys long-term success by continually adhering to Lean Manufacturing principles and maintaining a mature and robust ISO 13485 Quality Management System (QMS).

Early Concerns

Hologic’s long-term use of and familiarity with their QMS is a primary reason that, when ISO 14001 and OSHAS 18001 certification discussions began, there were well-founded assumptions regarding the implementation process. Among these assumptions were concerns that concurrently implementing an environmental management system and an occupational health and safety management system could be a long-term project lasting two years or more. The management team saw a need to prepare the operation to absorb the efforts and activities required to bring the organization through the process without being overburdened.

Especially interesting to Hologic’s management team was the search they began to identify external experts to assist in the ISO 14001 and OHSAS 18001 implementation process. Many were willing to take on the project, but it seemed difficult to locate a consultant with a methodology and an acceptable level of familiarity with concurrently facilitating both ISO 14001 and OHSAS 18001 implementation.

During the screening and interviews of candidates, Pinnacle Enterprise Group founder Kirill Liberman was given the opportunity to present an approach for the project that no other consulting organization offered – implementation of both standards at the same time and the development of a single integrated Environmental, Health and Safety Management System (EHS). Not only did Kirill Liberman suggest simultaneous implementation could be accomplished smoothly, but he demonstrated tools and a methodology specifically designed to guide the process – Pinnacle’s Lean EHS®.

With Pinnacle Enterprise Group on board, Hologic decided on attempting the combined ISO 14001 and OHSAS 18001 certification. They discovered not only that Pinnacle’s Lean EHS® implementation approach worked, but it also turned many of their previous concerns into non-issues, while creating immediate low-hanging fruit to benefit the operation.

A Vision Beyond ISO 14001 and OHSAS 18001 Certification

The Lean EHS® is a visual process-based methodology that applies Lean Management concepts – such as visual management, flow, and just-in-time – to the design of an ISO based management system infrastructure. Traditional non-value-added volumes of text procedures are replaced with process maps that provide both a view of each process and demonstrate its relationship to other processes of the business. The traditional documentation bureaucracy is replaced by a user-friendly visual interface that supports training, process analysis, and organic continual improvement.

This is exactly what Hologic discovered as they began to implement the Lean EHS®. There were really three factors that made the project successful.

First, by using the Lean EHS® developed by Pinnacle, Hologic easily reduced the amount of documentation created. Instead of large amounts of verbiage for personnel to grasp; the process maps at once become the ISO 14001 and OHSAS 18001 documentation and the EHS training tool. The visual aspects of the Lean EHS® simplified training and became more readily used by everyone because it helps them visually understand why and how each process is integral to the business.

“Training all employees is key to a successful launch of any initiative,” stated Greg Safarik, Vice President, Breast Health Manufacturing Operations. “The format used, offered simplicity with all the desired and required elements for certification.” he added.

Second, in order to complete both implementations together in less than 7 months, Pinnacle worked with Hologic to take advantage of all the requirements of each standard which are similar, identical, or related to each other. Therefore, ISO14001 and OHSAS 18001 were not viewed as two unique sets of requirements, but complimentary systems which add value to the business. Common processes reduced both documents and bureaucracy. This enabled Hologic to fit a two system implementation, which everyone thought would take as many years, into an efficient 7-month program.

Greg Safarik adds, “Senior management was convinced that we should get certified for ISO 14001 and [then] OHSAS 18001 the following year. After all the procedures were written and we [observed] the commonality between the two, we decided to get certified for both at the same time. Using guidelines of the Lean EHS® and integrating the two, we successfully received certification for both.”

Finally, Hologic saw the Lean EHS® could be used to enhance the business and to create immediate improvements by rapidly implementing best practices. The Lean EHS® created an environment of total company awareness and involvement in environmental health and safety. Instead of a project team and some key stakeholders attempting to push the project throughout the company, the entire organization became connected with implementing the program.

“People understand all of our systems better because we did this,” stated Jeffrey Joaquim Senior Manager, Corporate EHS, who lead Hologic’s implementation team. This process broadened their entire scope of knowing the business.

The results of the combined implementation and the entire program were significant focused business improvements. While the initial concern was burdening the operation with unnecessary tasks, the project leadership admits that both during implementation and after the certification they realized added value and cost savings.

Some of the lowest hanging fruit in operational savings came from energy conservation. Hologic reduced power consumption almost immediately. The cost to air condition the facility was also driven down. The company saw immediately measurable decreases in the amounts of waste being discharged by the plant.

Integral cost reductions went deeper than simply labor and materials enabling Hologic to reduce overhead using the knowledge and information learned through the combined systems. For example, the Lean EHS® helped Hologic drive down packaging costs through changes in packaging materials. Among the tangible results were a lower standard product cost, opportunity for increased margin, and competitive advantage.

In addition to the bottom line benefits, Hologic realized a decrease in its environmental footprint during the implementation. Today, the facility is proud of its zero contribution to landfill. Furthermore, the lessons learned created a trickle-down effect which resulted in reductions for the environmental footprint of suppliers. Hologic actually initiated requirements of their suppliers designed to facilitate best practices with Hologic. These practices ultimately contributed to business improvements for suppliers.

Even the auditors remarked positively not only concerning a successful audit with zero non-conformances, but they were able to clearly identify a number of positives the company had achieved. All parties are confident that the Lean EHS® will continue to gather momentum as it matures.

Industry:     Automotive, Telecommunication, Electronics, Manufacturing

Objectives:

• Improve and simplify the existing ISO 9001 quality management systems.
• Make the quality management system value-added for running the business.
• Integrate with and support Lean Manufacturing transformation
• Develop a practical Environmental Management System and achieve ISO 14001 certification.

Approach:

• Use Pinnacle’s Lean QMS® methodology to simplify existing QMS documentation and maintain ISO 9001 certification.
• Use Pinnacle’s Lean EMS® methodology to integrate the EMS with the QMS and achieve ISO 14001 certification.

Benefits:

• A management system that is more easily navigable than the previous text-based system.
• Increased personnel involvement in relating the process to every part of the business.
• A seamless, rapid integration of Lean EMS® (ISO 14001) with the visual Lean QMS® resulting with a single integrated management system.

“For many employees, having to consult a three page single spaced document for every procedure was drudgery. The visual system makes everything easy to relate to. We actually started getting input from people.”

Kendall Ymker, Management Representative

Lean QMS® and Lean EMS® Make Everyone Part of the Quality Process

RoMan Manufacturing is a leading manufacturer of transformers, power supplies, switches, and inverters. Their multiple departments occupy 3 buildings in Southwest Grand Rapids, Michigan. RoMan began to explore making a commitment to a formal quality management program when one of their automotive customers put a group of its suppliers on a timeline for QS 9000 T&E. After discovering that the customer’s QS 9000 T&E requirement didn’t apply to their operation, RoMan began to pursue ISO 9001 certification and contacted outside consulting firms to assist them.

Early in the process they reviewed the Pinnacle Lean QMS® and agreed that there were aspects of the Lean QMS® that would simplify their certification and possibly be more appealing to present to the employees. However, they began normal preparation for their registration audit and development of a text based system. As the process continued and the quality manual grew in content, the certification activity began to feel like a management-only team exercise. There was no lack of process material available but according to Kendall Ymker, Management Representative, it seemed like just that…”material, that didn’t have a feel linking it to the business.” It wasn’t that there was negative feedback regarding the ISO 9001 certification process, the personnel just weren’t in tune with what was taking place in the ISO 9001 implementation process.

About 5 months into the process after a successful registration audit, RoMan decided to convert to Pinnacle Enterprise Group’s visual Lean QMS®. The conversion took about 5 more months, but the results were more than worth the effort, according to Operations Manager Greg Garthe. “The text-based books and manuals were good, but no one really took the time to use them. It was difficult to look things up on the computer. The visual based system was much easier to follow. People can actually see what’s happening.”

With the conversion to Pinnacle Lean QMS®, the RoMan quality manual went from 100 pages of single spaced text, to a three page graphical overview, called the Lean QMS® Map. The Lean QMS® Map is then linked to 20 pages of process maps that describe every core and support process. “It was like going from the dark ages to the enlightenment,” stated Greg Garthe. “The visual system is very powerful.”

With the visual system created by the Lean QMS®, the ISO 9001 certification initiative was no longer a management team only exercise. The team began to receive input from a wide variety of personnel. “People actually stopped just sitting around the table and became involved,” said Kendall Ymker.

Not only did everyone begin sharing ideas for the certification process, but the system became an important tool for running the business. Even though there was no longer a customer requirement driving the need for certification, the leadership team and personnel alike felt the Lean QMS® truly represented the operation, and at the same time became the operation. RoMan uses it to run the business because it’s both the easiest way and the best way. “We live it, it’s what we do,” states Garthe.

For RoMan, beginning with the Lean QMS® also provided an important economy of scale for their Environmental Management System. They were able to pick any core process and develop its environmental aspects easily and visually. Using Pinnacle Enterprise Group’s Lean EMS®, RoMan was able to complete their ISO 14001 certification in less than 4 months, thanks to the system and culture which evolved during the ISO 9001 implementation process.

When asked whether using the Pinnacle system is cost effective, Ymker says, “It’s not even a question mark….just get it done!” Both the company leadership and personnel agree that it is easy to see the value.